Welcome to our dedicated page for Fortress Biotech news (Ticker: FBIO), a resource for investors and traders seeking the latest updates and insights on Fortress Biotech stock.
Fortress Biotech, Inc. (Nasdaq: FBIO) is a biopharmaceutical company that regularly issues news about its portfolio of prescription pharmaceutical products and development programs. Its press releases cover updates from Fortress itself and from majority-owned and partner companies that it has founded or supports, providing investors with a consolidated view of activity across oncology, dermatology and rare disease assets.
Recent announcements highlight regulatory milestones, clinical progress and transaction-driven events. Fortress and its majority-owned subsidiary Cyprium Therapeutics have reported U.S. Food and Drug Administration (FDA) approval of ZYCUBO (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients, noting that it is the first and only FDA-approved treatment for Menkes disease in the United States. Earlier updates described FDA acceptance of the resubmission of the New Drug Application for CUTX-101 and the transfer of development and commercialization responsibilities to Sentynl Therapeutics, with Cyprium eligible for royalties and milestone payments.
News related to Journey Medical Corporation, which was founded by Fortress, includes financial results driven by net revenues from dermatology products and the commercial launch of Emrosi (DFD-29) for inflammatory lesions of rosacea in adults. Releases also present clinical data, such as pooled Phase 3 analyses demonstrating Emrosi’s efficacy versus comparators, and discuss payer access and prescription trends.
Additional Fortress news items describe monetization events and pipeline updates, such as the acquisition of Checkpoint Therapeutics by Sun Pharma, the sale of dotinurad rights to Crystalys Therapeutics with associated equity and royalty interests, and the initiation of Phase 3 trials of dotinurad for gout by Crystalys. Investors following FBIO news can use this page to review these types of announcements, track regulatory interactions, and monitor how Fortress’ subsidiaries and partners contribute to the overall portfolio.
Fortress Biotech (FBIO) reported significant developments for 2024, including two FDA approvals: Emrosi™ for rosacea treatment and UNLOXCYT™ for advanced skin cancer. The company's subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma, expected to bring Fortress approximately $28 million at closing plus a 2.5% royalty on UNLOXCYT sales.
Key financial metrics for 2024 include consolidated net revenue of $57.7 million, down from $84.5 million in 2023. The company reported a net loss of $(55.9) million or $(2.69) per share, improved from $(68.7) million in 2023. Cash position stood at $57.3 million as of December 31, 2024.
Notable developments include FDA's acceptance of CUTX-101's New Drug Application for Menkes disease with a PDUFA date of September 30, 2025, and the commercial launch of Emrosi with first prescriptions filled.
Checkpoint Therapeutics (CKPT) announced significant developments in its 2024 financial results and corporate updates. The company secured FDA approval for UNLOXCYT™ (cosibelimab-ipdl), the first PD-L1 blocking antibody approved for treating advanced cutaneous squamous cell carcinoma. Additionally, CKPT entered into a merger agreement with Sun Pharmaceutical Industries valued at up to $416 million, expected to close in Q2 2025.
Financial highlights for 2024 include: Cash position increased to $6.6 million from $4.9 million in 2023, with an additional $38.1 million received post-year-end through warrant exercises. R&D expenses decreased to $36.2 million from $43.6 million, while G&A expenses increased to $20.1 million from $8.7 million. The company reported a net loss of $56.2 million ($1.42 per share) compared to $51.8 million ($3.17 per share) in 2023.
Journey Medical (DERM) reported its full-year 2024 financial results, with total revenues of $56.1 million, meeting all financial guidance targets. The company received FDA approval for Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) for rosacea treatment in November 2024, with initial distribution and first prescriptions already underway.
Key financial metrics include:
- Product revenue decreased 8% to $55.1 million from $59.7 million in 2023
- Net loss of $(14.7) million, or $(0.72) per share, compared to $(3.9) million in 2023
- Adjusted EBITDA of $0.8 million
- Cash position of $20.3 million as of December 31, 2024
The company's Phase 3 clinical trial results for Emrosi were published in JAMA Dermatology, demonstrating successful achievement of co-primary and secondary endpoints. Full promotion is expected to begin in April 2025.
Journey Medical (NASDAQ: DERM) has announced the launch and first prescriptions of Emrosi™, a 40 mg Minocycline Hydrochloride Modified-Release Capsule treatment for inflammatory lesions of rosacea in adults. The medication, which received FDA approval in November 2024, is now available through specialty pharmacy chains.
Emrosi is the lowest-dose oral minocycline available, featuring a unique 10 mg immediate release and 30 mg extended release formulation. Clinical trials demonstrated superior efficacy compared to Oracea® and placebo while maintaining a comparable safety profile. The most common adverse reaction reported was dyspepsia, occurring in ≥1% of subjects.
Journey Medical (Nasdaq: DERM) has scheduled the release of its year end 2024 financial results on Wednesday, March 26, 2025, after U.S. financial markets close. The commercial-stage pharmaceutical company, which specializes in marketing FDA-approved prescription pharmaceutical products for dermatological conditions, will host a conference call and audio webcast at 4:30 p.m. ET on the same day.
Interested U.S. participants can dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international) to join the conference call. Registration is available at https://dpregister.com/sreg/10197674/feaf5b7354. A live audio webcast will be accessible on the company's website and remain available for approximately 30 days after the call.
Fortress Biotech (FBIO) and Partex NV have announced a strategic collaboration to leverage artificial intelligence for biopharmaceutical asset identification and evaluation. The partnership combines Fortress' expertise in identifying and developing promising assets with Partex's proprietary AI-based drug discovery platform.
Partex's technology will provide comprehensive analyses including target identification, indication expansion, and molecular profiling to accelerate bringing therapeutics to market. The collaboration aims to support Fortress' business model of acquiring and advancing assets to enhance shareholder value through product revenue, equity holdings, and dividend and royalty revenue.
Fortress currently has a late-stage pipeline, two recently approved medicines, and another candidate with a PDUFA date in Q3 2025. The company expects this AI collaboration to enable more efficient and cost-effective scaling of their asset evaluation process.
Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company focused on marketing FDA-approved dermatological prescription products, has announced its participation in the 37th Annual ROTH Conference from March 16-18, 2025, in Dana Point, California.
President and CEO Claude Maraoui will lead a fireside chat on Tuesday, March 18 at 12:30 p.m. PT and will be available for one-on-one meetings throughout the conference. Investors can access the fireside chat webcast on Journey Medical's website investor section for approximately 30 days following the event.
Sun Pharma has announced the acquisition of Checkpoint Therapeutics (CKPT) in a deal valued at up to $355 million, offering $4.10 per share in upfront cash payment plus a contingent value right of up to $0.70 per share. The acquisition centers on UNLOXCYT™ (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC).
The deal represents a 66% premium to Checkpoint's closing price on March 7, 2025. The transaction, expected to close in Q2 2025, requires stockholder and regulatory approvals. Checkpoint reported minimal revenue of $0.04 million and a net loss of $27.3 million for the nine months ending September 2024, with R&D expenses of $19.3 million.
Fortress Biotech, Checkpoint's controlling stockholder, will receive royalty payments based on future cosibelimab sales and has agreed to vote in favor of the transaction.
Journey Medical (NASDAQ: DERM) announced the publication of Phase 3 clinical trial results for Emrosi™ (DFD-29) in JAMA Dermatology. The trials demonstrated superior efficacy of DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules) compared to both Oracea® and placebo in treating rosacea.
Key findings from the MVOR-1 and MVOR-2 trials showed:
- DFD-29 achieved 65.0% and 60.1% IGA treatment success rates respectively
- Significant reduction in inflammatory lesions compared to alternatives
- Superior reduction in erythema versus placebo
- No major safety issues reported
The FDA approved Emrosi™ in November 2024 for treating inflammatory lesions of rosacea in adults, with launch expected in early spring 2025.
Journey Medical (Nasdaq: DERM) announced its participation in the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida, from March 7-11, 2025. The company will showcase Emrosi™, their newly FDA-approved treatment for inflammatory lesions of rosacea in adults, approved in November 2024.
Emrosi™, featuring 40 mg Minocycline Hydrochloride Modified-Release Capsules (10 mg immediate release and 30 mg extended release), is positioned as the lowest-dose oral minocycline available. According to the company, it demonstrates superior clinical outcomes for rosacea compared to placebo and Oracea® while maintaining a comparable safety profile.
The AAD annual meeting, with over 350 exhibitors and nearly 20,000 attendees, including 10,000+ medical personnel, will provide Journey Medical an opportunity to present their dermatology product portfolio at booth 2181.